IVC (inferior vena cava) filters can be implanted to protect patients against pulmonary embolism. Complications from the procedure are rare. However, we have learned of instances where the filters are placed in patients who do not need them or where they are left in patients far longer than they are needed. Under Ohio law, a medical negligence claim can arise out of complications from an unnecessary procedure. Likewise, a medical negligence claim can arise out of complications that occur due to inadequate followup.
Increasingly, we are learning about medical complications arising out of invasive procedures that are unnecessary. In the context of IVC filters, we recently represented the estate of a gentlemen who died from complications of an IVC filter that he didn’t need. That case resulted in a confidential settlement.
A recent report by the FDA showcases another problem with IVC filters: the failure to remove them after they are no longer needed. Newer filters can be retrieved, using the same low-risk procedure employed for placement. However, if a filter is left in that is no longer needed, the patient is put at risk. In this regard, the FDA reported the following:
“Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. The FDA encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated.”
The procedure for placing filters is considered to be minimally invasive in that a small incision is made so that the filter can be placed using a catheter. Given the fact that complications related to the device are rare, profit-oriented physicians may be inclined to recommend the procedure even if it is not medically indicated. Likewise, if doctors do not monitor patients properly, a retrievable filter can be left for too long, allowing for deterioration, perforation, migration or other avoidable injury.
Nearly a quarter-million of these devices were implanted last year alone, and usage is increasing. The risk of medical malpractice will rise along with this trend.